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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
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Phase II study using Proton radiation therapy to treat males, aged 18 years or older, with Stage I, IIA and IIB Seminoma. This research study will be done in conjunction with the Robert H. Burr Proton Therapy Center at the Mass. General Hospital and the Department of Defense. In the feasibility portion of the study patients will be evaluated to determine acute toxicity. If the study is deemed feasible the principal investigator (PI) hopes that proton RT will reduce the lethargy rate as compared to photon radiation therapy (RT).
This is a Phase II study using proton radiation therapy in addition to their standard care in subjects who have Stage I, IIA, IIB Seminoma. Testicular cancer are the most common solid cancers among men aged 20 to 35. Each subject must be 18 years of age or older and have a histologically proven diagnosis of testicular cancer. In addition to a subject's routine exams and tests, they will be asked to complete a series of quality of life questionnaires before, during and after their treatment. All side effects/toxicities will be monitored and recorded. Patients will be followed for a minimum of 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton RT | Experimental | Subjects receive proton radiation for seminoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Radiation Therapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events | 5 years |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Justin Bekelman, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Jason Efstathiou, MD, Ph.D. | Massachusettes General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusettes General Hospital | Boston | Massachusetts | United States | |||
| Abramson Cancer Center of the University of Pennsylvania |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proton RT | Subjects receive proton radiation for seminoma Proton Radiation Therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Proton RT | Subjects receive proton radiation for seminoma Proton Radiation Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Serious Adverse Events | Posted | Count of Participants | Participants | 5 years |
|
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Proton RT | Subjects receive proton radiation for seminoma Proton Radiation Therapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Justin E. Bekelman, MD | University of Pennsylvania | (215)662-7292 | bekelman@xrt.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2014 | Nov 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011522 | Protons |
| ID | Term |
|---|---|
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 |
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| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 5 |
| 5 |
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Dermatitis radiation | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
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| Erythema multiforme | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Other Gastrointestinal disorders | Gastrointestinal disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Work Stress | Social circumstances | Non-systematic Assessment |
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| Testicular pain | Reproductive system and breast disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Weight gain | Investigations | Non-systematic Assessment |
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| Weight loss | Investigations | Non-systematic Assessment |
|
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| Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |